Ex Parte Sanders et alDownload PDFPatent Trial and Appeal BoardMar 2, 201612669145 (P.T.A.B. Mar. 2, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/669,145 06/15/2010 52034 7590 03/24/2016 Parker Highlander PLLC 1120 South Capital of Texas Highway Bldg. 1, Suite 200 AUSTIN, TX 78746 FIRST NAMED INVENTOR Bob G. Sanders UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. CLFR:276US 1892 EXAMINER RAMACHANDRAN, UMAMAHESW ARI ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 03/24/2016 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): docket@phiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BOB G. SANDERS and KIMBERLY KLINE Appeal2013-007918 Application 12/669,145 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and JACQUELINE T. HARLOW, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL 1 This appeal under 35 U.S.C. § 134(a) involves claims 7-11 and 16-18 (January 2, 2013 Advisory Action). Examiner entered rejections under 35 U.S.C. § 103(a) and obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. STATEMENT OF THE CASE Appellants disclose "[ m ]ethods [] for treating subjects with chroman ring compounds such as vitamin E derivatives" (Spec. i-f 2). Claims 7, 17, 1 Appellants identify the Real Party in Interest as "Research Development Foundation" (App. Br. 2). Appeal2013-007918 Application 12/669,145 and 18 are representative and reproduced in the Claims Appendix of Appellants' Brief. Claims 7-11, 17, and 18 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Sanders '998, 2 Dominguez, 3 and Bose. 4 Claim 16 stands rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Sanders '998 and Clark. 5 Claims 7-11 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of Sanders '223 6 in combination with Sanders '998 and Dominguez. Claims 7-11 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of Sanders '638 7 in combination with Sanders '998 and Dominguez. Claims 7-11 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of Sanders '424 8 in combination with Sanders '998 and Dominguez. 2 Sanders et al., US 6,645,998 B2, issued Nov. 11, 2003. 3 Gemma Dominguez, et al., Wild type p73 overexpression and high-grade malignancy in breast cancer, 66 Breast Cancer Research and Treatment 183-190 (2001). 4 Shikha Bose et al., The Akt pathway in human breast cancer: a tissue- array-based analysis, 19 Modem Pathology 238-245 (2006). 5 Amy S. Clark et al., Constitutive and Inducible AKT Activity Promotes Resistance to Chemotherapy, Trastuzumab, or Tamoxifen in Breast Cancer Cells, 1 Molecular Cancer Therapeutics 707-717 (2002). 6 Sanders et al., US 6,417,223 Bl, issued July 9, 2002. 7 Sanders et al., US 7,608,638 B2, issued Oct. 27, 2009. 8 Sanders et al., US 8,148,424 B2, issued Apr. 3, 2012. 2 Appeal2013-007918 Application 12/669,145 Claims 7-11 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of Sanders '998 in combination with Dominguez. Claims 7-11 and 16 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of Sanders '9549 in combination with Dominguez. Claims 7-11 stand rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over the claims of Sanders '232 10 in combination with Dominguez. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Sanders '998 "relates to chroman-based compounds and derivatives thereof, and their uses as cell anti-proliferative, proapoptotic, immunomodulating, and anti-viral agents" (Sanders '998 1: 18-21; see Ans. 6 and 7). FF 2. Sanders '998 exemplifies the synthesis and characterization of, inter alia, the chroman ring derivative compound: 2,5,7,8-tetramethyl-(2R- ( 4R,8R, 12-trimethyltridecyl)chroman-6-yloxy)acetic acid (a-TEA) (Sanders '998 8: 26----67; see generally Final Rej. 13; Ans. 6 and 7). 9 Sanders et al., US 7,300,954 B2, issued Nov. 27, 2007. 10 Sanders et al., US 7,312,232 B2, issued Dec. 25, 2007. 3 Appeal2013-007918 Application 12/669,145 FF 3. Sanders '998 discloses a method for the treatment of a cell proliferative disease comprising administering to an animal a pharmacologically effective dose of a chroman-based compound such as 2,5, 7 ,8-tetramethyl-(2R-( 4R,8R,12-trimethyltridecyl)chroman-6- yloxy)acetic acid (a-TEA) (Sanders '998 38: 2-29; see also id. at 11. 30-33 (A method for treating a cell proliferative disease comprising the administration to an animal a pharmacologically effective dose of 2,5,7,8- tetramethyl-(2R-(4R,8R,12-trimethyltridecyl)chroman-6-yloxy)acetic acid (a-TEA); see Final Rej. 13; Ans. 6 and 7). FF 4. Sanders '998 discloses a method for the treatment of a cell proliferative disease, wherein the neoplastic disease is selected from the group consisting of ovarian cancer, cervical cancer, endometrial cancer, bladder cancer, lung cancer, breast cancer, testicular cancer, prostate cancer, gliomas, fibrosarcomas, retinoblastomas, melanomas, soft tissue sarcomas, ostersarcomas [sic], leukemias, colon cancer, carcinoma of the kidney, pancreatic cancer, basal cell carcinoma, and squamous cell carcinoma (Sanders '998 38: 66- 39: 6 (emphasis added); see generally Final Rej. 13; Ans. 6 and 7.) FF 5. Examiner finds that Sanders fails to disclose that the cancer cells in the patient overexpress one or more of, Arg, p73, NOXA, or FOXOl gene (Final Rej. 13). FF 6. Dominquez discloses that a percentage of patients with breast carcinoma overexpress p73 (Dominguez, Abstract). FF 7. Examiner finds that Dominguez [] teaches overexpression of p73 is a molecular alteration that could be implicated in the tumorigenesis of breast carcinomas (see abstract). The reference in the 4 Appeal2013-007918 Application 12/669,145 ["]Methods["] section (p 184) teaches collecting samples from the patients and then testing the samples for overexpression of p73 between breast tumor and normal breast tissues (see Fig. 1 ). Thus Dominguez teaches the step of obtaining samples from the patients, determining whether such samples express p73 or not. (Final Rej. 13 ( emphasis added).) FF 8. Examiner finds that the combination of Sanders and Dominguez fails to "explicitly teach the cancer cells expresses two or more of p73, FOXO 1 [,] Arg[,] or NOXA genes in [cancer] patients" (Final Rej. 14). FF 9. Examiner finds that Bose discloses that a percentage of patients with breast carcinoma overexpress FKHR (FOXOl) (Final Rej. 14 (emphasis added); see generally Spec. i-fi-141, 136 (FKHR is another name for FOXOl)). FF 10. Sanders does not suggest cells that "do not comprise a constitutively active Akt kinase" (Final Rej. 15) FF 11. Examiner relies on Clark to suggest breast cancer cells that do not have a constitutively active Akt kinase (Final Rej. 15). ANALYSIS The method of Appellants' claim 7 comprises the administration of an effective amount of a chroman ring derivative compound that is alpha-TEA (2,5,7,8-tetramethyl-(2R-(4R,8R,12-trimethyltridecyl)chroman-6- yloxy)acetic acid) to a breast cancer patient, wherein the cancer of the 5 Appeal2013-007918 Application 12/669,145 patient comprises breast cancer cells that overexpress an Arg, p73, NOXA or FOXOl gene (see Appellants' claim 7). 11 Appellants' claim 16 depends from and further limits the cancer cells of claim 7 to cells that do not comprise a constitutively active Akt kinase (see Appellants' claim 16). Appellants' claim 1 7 depends from and further limits the cancer patient of claim 7 to a patient who was previously determined to have a cancer that comprises cancer cells that overexpress an Arg, p73, NOXA or FOXOl gene (see Appellants' claim 17). Appellants' claim 18 depends from and further limits the cancer patient of claim 17 to a patient who was previously determined to have a cancer that comprises cancer cells that overexpress at least two of an Arg, p73, NOXA or FOXOl gene (see Appellants' claim 18). The combination of Sanders '998, Dominguez, and Bose: Based on the combination of Sanders '998, Dominguez, and Bose, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to use the method disclosed by Sanders '998 to treat patients with breast cancer, which one of ordinary skill in this art would have expected to include a percentage of patients with cancer cells that overexpress p73 and/or FOXOl (Final Rej. 13-14; FF 1-9). In this regard, Examiner finds that, at the time of Appellants' claimed 11 Appellants contend that "by virtue of a species election dated 5 .16 .12, the examination of the claims is currently limited to the use of alpha-TEA (2,5,7,8-tetramethyl-(2R-(4R,8R,12-trimethyltridecyl)chroman-6- yloxy)acetic acid) for the treatment of breast cancer" (App. Br. 2; see also Ans. 3). 6 Appeal2013-007918 Application 12/669,145 invention, a person of ordinary skill in this art would have found it prima facie obvious to "have tested the cancer cells to determine whether the cell[s] express[] two or more of Arg, p73, NOXA or FOXOl gene[s] because Dominguez [and Bose] teach that p73 [and] FKHR (FOXOl)" are overexpressed in breast carcinoma cells (Final Rej. 14 ). Claim 7: Appellants do not dispute that Sanders '998 discloses a method for the treatment of breast cancer comprising administering to an animal a pharmacologically effective dose of a-TEA (see FF 1--4; cf App. Br. 4---6; Reply Br. 1-3). Appellants do not dispute that Dominguez and Bose disclose that a percentage of breast cancer cells overexpress p73 and/or FOXOl (see FF 6, 7, and 9; cf App. Br. 5; Reply Br. 1-3). Thus, the evidence of record supports a conclusion that breast cancer patients having cells that overexpress p73 and/or FOXOl are among the genus of patients Sanders '998's method is designed to treat (Ans. 7). We recognize, but are not persuaded by, Appellants' unsupported intimation that a person of ordinary skill in this art, e.g., a practicing physician, would not check for the expression of a known breast cancer marker, such as the overexpression of p73 and/or FOXOl, prior to initiating a breast cancer treatment as suggested by Sanders '998 (see App. Br. 5; cf FF 1-9). We recognize, but are not persuaded by, Appellants' unsupported intimation that a person of ordinary skill in the art would not, due to the expense, perform screening methods to determine the type of cancer a patient exhibits prior to initiating a known treatment protocol for a particular cancer (App. Br. 5). 7 Appeal2013-007918 Application 12/669,145 Claim 17: For the foregoing reasons we are not persuaded by Appellants' contention that Examiner's assertion that pre-testing or cancer screening, as suggested by Dominguez and Bose, as a preliminary step to cancer treatment "does not rise to the kind of reasoned scientific analysis contemplated by MPEP 2144 and 2143.01" (see App. Br. 5---6; see generally Final Rej. 14). Claim 18: For the foregoing reasons we are not persuaded by Appellants' contention that "claim 18['s] require[ment] [for] testing of patient's cancer to determine whether at least two of the four specified genes is submitted to be even further removed from the prior art, for the same reasons mentioned in the aforementioned paragraph" (App. Br. 6). The combination of Sanders '998 and Clark: Based on the combination of Sanders '998 and Clark, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious to treat breast cancer patients, including those who have cancer cells that do not constitutively express Akt kinase (Final Rej. 15). Appellants' claim 16 does not require increased a-TEA activity, therefore we are not persuaded by Appellants' contention that "[ t ]here is simply no teaching or suggestion in Clark to in any way tie reduced Akt activity to increased a-TEA activity" (App. Br. 6). 8 Appeal2013-007918 Application 12/669,145 Unexpected Results: We recognize, but are not persuaded by, Appellants' contention that the Examples presented in their Specification establish an unexpected property or result for their claimed invention (see e.g., App. Br. 4; Reply Br. 2--4). Sanders '998 discloses a method of treating cell proliferative disease, including breast cancer, by administering, to the animal, a pharmacologically effective dose of a-TEA (FF 1--4). The prior art of record further establishes that a population of patients with breast cancer in the genus disclosed by Sanders '998 will overexpress p73 and/or FOXOl (FF 6, 7, and 9). In contrast, Appellants may have, at best, established the mechanism of action through which a-TEA works in some specific cell lines, which may or may not correlate to the cancers disclosed by Sanders '998 and encompassed by Appellants' claimed invention (see e.g., Spec. i-fi-f 117, 118, 132-136, and 138-145). Simply stated, Appellants' evidence fails to establish an unexpected result associated with the discovery of the foregoing mechanism of action. CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness. The rejection of claims 7, 17, and 18 under 35 U.S.C. § 103(a) as unpatentable over the combination of Sanders '998, Dominguez, and Bose is affirmed. Claims 8-11 are not separately argued and fall with claim 7. The rejection of claim 16 under 35 U.S.C. § 103(a) as unpatentable over the combination of Sanders '998 and Clark is affirmed. 9 Appeal2013-007918 Application 12/669,145 Obviousness-type Double Patenting: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness-type double patenting? ANALYSIS For the reasons set forth above, we recognize, but are not persuaded by, Appellants' reliance on "Section IV.A." of Appellants' Brief for their response to each of Examiner's obviousness-type double patenting rejections on this record (see App. Br. 7). CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner supports a conclusion of obviousness-type double patenting. The obviousness-type double patenting rejections are affirmed. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 10 Copy with citationCopy as parenthetical citation